Edgewood Oncology has treated the first two subjects in the Phase IIa clinical trial of BTX-A51, targeting patients with metastatic breast cancer.
This marks a significant step in the development of the multi-specific kinase inhibitor, which is being investigated for its potential to treat estrogen receptor-positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer, including cases with GATA3 mutations.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The multicentre, open-label, nonrandomised, multiple dose study is designed to assess the safety, toxicity, pharmacokinetics, and preliminary efficacy of BTX-A51.
Patients with ER+/HER2- metastatic breast cancer both with and without GATA3 mutations are being enrolled at various sites, which are now open for participation.
BTX-A51 functions by inhibiting casein kinase 1 alpha (CK1α) and cyclin-dependent kinases 7 and 9 (CDK7 and CDK9). These are considered master regulators in the progression of cancer.
Edgewood Oncology chief medical officer Zung Thai said: “This represents an important milestone for both Edgewood Oncology and for patients with ER+/HER2- breast cancer, particularly those with a GATA3 mutation, who need better treatment options targeted to their underlying mutation profile.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“Moreover, while CDK4/6 inhibitors remain a cornerstone of current treatment regimens, resistance to these therapies poses a formidable challenge. By targeting CDK7 and CDK9, key regulators of cell cycle progression, BTX-A51 not only aims to circumvent this resistance but also to transform the treatment landscape.”
In March, the company secured $20m in Series A to advance the clinical development of its lead cancer therapy BTX-A51.
The Series A funding round was led by US-based venture fund Alta Partners. Edgewood Oncology expects the funds to finance multiple clinical trials into 2026.
